Study of Interferon-Gamma in the Complex Treatment of Patients Infected With HIV and Tuberculosis

A I//II Phase Study of the Efficacy and Safety of Interferon-Gamma by Subcutaneous Injection in the Complex Treatment of Patients Infected With HIV and Tuberculosis

The primary purpose of this study is to assess the safety and efficacy of interferon-gamma by subcutaneous injection in complex treatment of patients with co-infection of HIV and pulmonary tuberculosis and to determine the rational of its use.

Study will evaluate safety and efficacy of the investigational medical product (IMP) - interferon-gamma - in participants with HIV-infection and pulmonary tuberculosis.

Interferon-gamma (immune interferon) is an important anti-inflammatory cytokine produced by NK-cells, CD4 Th1 cells and CD8 cytotoxic supressor cells. Interferon-gamma blocks viral replication, viral proteins synthesis and assembly of mature viral particles. Causes cytotoxic effects on the cells infected by intracellular pathogens. Possess a bright immunomoduling action. Thus, the use of interferon-gamma is patogenetically rational in patients co-infected with tuberculosis and HIV.

The aim of interferon-gamma use is to achieve a viral replication control, support CD4 level and help abacillation process. In this randomised, controlled safety and efficacy study interferon gamma will be administered in a daily dose of 500,000 IU daily or every other day.

The treatment regimen in this study will also include a basic antituberculosis therapy.

The available clinical data do not suggest a risk for serious adverse events (SAEs) from the IMP used in chosen doses.

The study will screen HIV-infected participants 18-50 years old with pulmonary tuberculosis. Participants who provide informed consent and meet study entry criteria will be randomised into 1 of 3 parallel treatment groups. The study will last 30 days, during which participants will receive IMP in various regimens according to the group.

Inclusion Criteria:

• Participants must sign the form of informed consent and agree to follow the protocol requirements
• Women willing to participate in the study must protect against possible pregnancy during all the study long
• Age 18-50 years
• Pulmonary tuberculosis
• HIV/AIDS
• Indication for in-patient standard antituberculosis treatment

Exclusion Criteria:

• Investigational research agents received within 30 days before the screening and participation in other clinical trials
• Immunosuppressive medications received within 6 months before the screening
• Current drug abuse for more than 3 years
• Contraindications to interferons of standard antimicrobial therapy